Primary Device ID | 14560189212807 |
NIH Device Record Key | 9a723d0f-d3c4-4787-81a9-e72e4fbba1d6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AIA-PACK Homocysteine Control Set |
Version Model Number | N/A |
Company DUNS | 690571724 |
Company Name | TOSOH CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com | |
Phone | 650-615-8134 |
Dave.Wurtz@tosoh.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04560189212800 [Primary] |
GS1 | 14560189212807 [Package] Contains: 04560189212800 Package: [6 Units] In Commercial Distribution |
JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-04-01 |
Device Publish Date | 2019-07-25 |
14560189212234 - AIA-PACK AFP Calibration Verification Test Set | 2024-04-01 |
14560189212241 - AIA-PACK CEA Calibration Verification Test Set | 2024-04-01 |
14560189212258 - AIA-PACK FER Calibration Verification Test Set | 2024-04-01 |
14560189212272 - AIA-PACK PAP CALIBRATION VERIFICATION TEST SET | 2024-04-01 |
14560189212296 - AIA-PACK bHCG Calibration Verification Test Set | 2024-04-01 |
14560189212807 - AIA-PACK Homocysteine Control Set | 2024-04-01 |
14560189212807 - AIA-PACK Homocysteine Control Set | 2024-04-01 |
14560189211190 - AIA-PACK FT3 Calibrator Set | 2024-02-14 |
14560189211213 - AIA-PACK TT3 SAMPLE DILUTING SOLUTION | 2024-02-14 |